SAN ANTONIO--(BUSINESS WIRE)--Feb 1, 2008 - Data from an integrated
analysis of three randomized, placebo-controlled trials showed
patients with moderate to severe plaque psoriasis receiving
REMICADE(R) (infliximab) achieved a consistently high level of skin
clearance in each of the four body regions (head, trunk, lower and
upper extremities) as measured by the Psoriasis Area Severity Index
(PASI). At week 10 of the analysis, which included nearly 1,500
subjects, 71 percent of patients receiving REMICADE 3 mg/kg and 79
percent of patients receiving REMICADE 5 mg/kg achieved a PASI 75,
or at least a 75 percent improvement in the chronic inflammatory
condition, compared with three percent of patients receiving
placebo (both P less than 0.001). Additionally, 39 percent and 52
percent of patients receiving REMICADE 3 mg/kg and 5 mg/kg,
respectively, achieved a PASI 90, or nearly complete skin
clearance, versus one percent of patients receiving placebo (both P
less than 0.001). Investigators reported these findings at the 66th
Annual Meeting of the American Academy of Dermatology.

In September 2006, the U.S. Food and Drug Administration (FDA)
approved REMICADE (5 mg/kg) for the treatment of chronic severe
plaque psoriasis. Following an initial three infusion treatments
(induction regimen), REMICADE is given once every eight weeks, or
as few as six times a year.

"This analysis shows that treatment with REMICADE resulted in a
consistently high level of clinical response in each quadrant of
the body evaluated by PASI, and the results were consistent with
patients' overall psoriasis improvement," said Alan Menter, MD,
dermatologist, Baylor Research Institute, Dallas, and lead study
investigator. "REMICADE remains an important advancement and
biologic treatment option for a broad spectrum of patients with
severe psoriasis."

According to findings presented by investigators, in each of the
three psoriasis clinical trials evaluated, the Study of Psoriasis
with Infliximab (REMICADE) Induction Therapy (SPIRIT), the European
Infliximab for Psoriasis (REMICADE) Efficacy and Safety Study
(EXPRESS), and the Evaluation of Infliximab for Psoriasis in a
(REMICADE) Efficacy and Safety Study (EXPRESS II), a substantial
proportion of REMICADE-treated patients experienced dramatic
improvements in head- and neck-related psoriasis, trunk psoriasis
and psoriasis of the lower and upper extremities as compared with
the placebo group. Additionally, the improvements in each body
region were generally consistent with the overall PASI response. At
week 10, the proportions of patients achieving at least a 75
percent improvement or at least a 90 percent improvement of head
and neck-related psoriasis in the combined REMICADE groups (3 mg/kg
and 5 mg/kg) versus placebo were as follows: SPIRIT, 86 percent
versus 22 percent achieved at least 75 percent improvement and 69
percent versus 12 percent achieved at least 90 percent improvement;
EXPRESS, 85 percent versus 13 percent achieved at least 75 percent
improvement and 73 percent versus 8 percent achieved at least 90
percent improvement; EXPRESS II, 79 percent versus 10 percent
achieved at least 75 percent improvement and 67 percent versus 6
percent achieved at least 90 percent improvement.

Further results from the integrated analysis were published in
the summer 2007 issue of the Psoriasis Forum, a journal of the
National Psoriasis Foundation, and showed the consistency of
REMICADE response across subgroups defined by a variety of baseline
demographic and disease characteristics in patients with psoriasis.
REMICADE was similarly effective regardless of previous use of
phototherapy or major conventional systemic therapies.(1)

About EXPRESS

EXPRESS was a Phase 3, multi-center, randomized, double-blind,
placebo-controlled trial that evaluated the safety and efficacy of
REMICADE induction and maintenance therapy in 378 adult patients
with chronic, stable plaque psoriasis involving at least 10 percent
body surface area (BSA), a minimum PASI score of 12 and who were
candidates for phototherapy or systemic therapy. Patients received
either REMICADE 5 mg/kg or placebo administered at weeks 0, 2 and
6, followed by maintenance treatment every 8 weeks. The REMICADE
group continued on maintenance treatments every 8 weeks. Patients
in the placebo group were crossed over at week 24 to receive
REMICADE 5 mg/kg at weeks 24, 26 and 30, then every 8 weeks through
week 46.

In EXPRESS, through week 24, adverse events (AEs) occurred at a
higher incidence in the REMICADE group (82 percent) compared with
the placebo group (71 percent). The only clinically significant
laboratory abnormalities that occurred more frequently in the
REMICADE group compared with the placebo group were elevated liver
enzyme tests. There were more serious AEs (6 percent), including
one fatal infection, in the REMICADE group than in the placebo
group (3 percent). AEs observed were generally consistent with
those described in the prescribing information, including
information regarding serious infections. Please see "Important
Safety Information" below.

About EXPRESS II

EXPRESS II was a Phase 3, multi-center, randomized,
double-blind, placebo-controlled trial that evaluated the safety
and efficacy of REMICADE in 835 adult patients with chronic, stable
plaque psoriasis involving at least 10 percent BSA, a minimum PASI
score of 12 and who were candidates for phototherapy or systemic
therapy. Patients were randomized to induction doses of REMICADE 3
mg/kg or 5 mg/kg or placebo at weeks 0, 2 and 6. Patients in the
active induction treatment groups were randomized again at week 14
to receive either scheduled or "as-needed" maintenance treatment at
the same dose administered during the induction phase. Patients in
the placebo group were crossed over at week 16 to receive REMICADE
5 mg/kg at weeks 16, 18 and 22, then every 8 weeks through week
46.

In EXPRESS II, through week 14 (the placebo-controlled period),
AEs occurred at a higher incidence in the REMICADE groups (63
percent and 69 percent with 3 mg/kg and 5 mg/kg, respectively),
compared with the placebo group (56 percent). The only clinically
significant laboratory abnormalities that occurred more frequently
in the REMICADE group compared with the placebo group were elevated
liver enzyme tests. Serious AEs occurred at rates of 2 percent in
the placebo group, 3 percent in the 5 mg/kg group and 1 percent in
the 3 mg/kg group. AEs observed were generally consistent with
those described in the prescribing information, including
information regarding serious infections. Please see "Important
Safety Information" below.

About SPIRIT

SPIRIT was a Phase 2, multi-center, double-blind,
placebo-controlled study evaluating the use of REMICADE induction
therapy in 249 people with severe plaque psoriasis who had
previously received psoralen plus ultraviolet light A (PUVA) or
systemic therapy for psoriasis. Trial participants were randomized
to receive REMICADE 3 mg/kg, REMICADE 5 mg/kg or placebo at weeks
0, 2, and 6 and were assessed biweekly for 10 weeks. At week 26,
patients whose Physician Global Assessment (PGA) score indicated
moderate to severe disease (n=114) were eligible for one additional
infusion of their assigned treatment to assess the safety of
retreatment after a 20-week treatment-free period.

In the SPIRIT trial, the percentage of patients with one or more
AE was higher in the REMICADE groups compared with placebo. Through
week 30 of the SPIRIT trial, 63 percent, 78 percent and 79 percent
of patients in the placebo, REMICADE 3 mg/kg and 5 mg/kg groups,
respectively, reported one or more AE. The most commonly reported
side effects versus placebo were upper respiratory tract infection
(15 percent versus 14 percent), headache (15 percent versus 8
percent) and itching (12 percent versus 0 percent). A total of 6
percent of REMICADE-treated patients reported serious AEs, compared
with zero patients in the placebo group. Overall, the AEs were
consistent with those seen in previous trials. Please see
"Important Safety Information" below.

About Psoriasis

Psoriasis is a chronic, immune-mediated disorder, which results
from inflammation in the skin and overproduction of skin cells that
accumulate on the surface causing red, scaly plaques that may itch
and bleed. This chronic inflammation is driven in part by tumor
necrosis factor alpha, or TNF-alpha, a cytokine involved in the
body's normal immune response. TNF-alpha is found at increased
levels in psoriatic plaques and plays a crucial part in their
formation and continued existence. It is estimated that 2 percent
of the U.S. population has psoriasis, and about 30 percent of
people with psoriasis have cases that are considered moderate to
severe.

About REMICADE

REMICADE is the global market leader among anti-tumor necrosis
factor alpha (TNF-alpha) therapies and is the only anti-TNF-alpha
treatment approved in three different therapeutic areas:
gastroenterology, rheumatology and dermatology. REMICADE has
demonstrated broad clinical utility in Crohn's disease (CD),
rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic
arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease
(PCD) and psoriasis (PsO). The safety and efficacy of REMICADE have
been well established in clinical trials over the past 14 years and
with more than one million patients treated worldwide through
commercial experience.

In the U.S., REMICADE is approved for the following
indications:

-- Reducing signs and symptoms, inhibiting the progression of
structural damage and improving physical function in patients with
moderately to severely active RA, when administered in combination
with methotrexate.

-- Reducing signs and symptoms in patients with active AS.

-- Reducing signs and symptoms and inducing and maintaining
clinical remission in adult and pediatric patients with moderately
to severely active CD who have had an inadequate response to
conventional therapy.

-- Reducing the number of draining enterocutaneous and
rectovaginal fistulas and maintaining fistula closure in adult
patients with fistulizing CD.

-- Reducing signs and symptoms, inducing and maintaining
clinical remission and mucosal healing, and eliminating
corticosteroid use in patients with moderately to severely active
UC who have had an inadequate response to conventional therapy.

-- Reducing signs and symptoms of active arthritis, inhibiting
the progression of structural damage and improving physical
function in patients with PsA.

-- Treatment of adult patients with chronic severe plaque PsO
who are candidates for systemic therapy and when other systemic
therapies are medically less appropriate.

REMICADE is unique among available anti-TNF biologic therapies.
Unlike self-administered therapies that require patients to inject
themselves frequently, REMICADE is the only anti-TNF biologic
administered directly by caregivers in the clinic or office
setting. REMICADE is a two-hour infusion administered every 6 or 8
weeks (indication-dependent), following a standard induction
regimen that requires treatment at weeks 0, 2 and 6. As a result,
REMICADE patients may require as few as six treatments each
year.

Important Safety Information

There are reports of serious infections, including tuberculosis
(TB), sepsis and pneumonia. Some of these infections have been
fatal. Tell your doctor if you have had recent or past exposure to
people with TB. Your doctor will evaluate you for TB and perform a
TB test. If you have latent (inactive) TB, your doctor should begin
TB treatment before you start REMICADE. REMICADE can lower your
ability to fight infections, so if you are prone to or have a
history of infections, or develop any signs of an infection such as
fever, fatigue, cough, flu or warm, red or painful skin while
taking REMICADE, tell your doctor right away. Also, tell your
doctor if you are scheduled to receive a vaccine or if you have
lived in a region where histoplasmosis or coccidioidomycosis is
common.

Reports of a type of blood cancer called lymphoma in patients on
REMICADE or other TNF blockers are rare but occur more often than
expected for people in general. People who have been treated for
rheumatoid arthritis, Crohn's disease, ankylosing spondylitis,
psoriatic arthritis, or plaque psoriasis for a long time,
particularly those with highly active disease may be more prone to
develop lymphoma. Cancers, other than lymphoma, have also been
reported. Children and young adults who have been treated for
Crohn's disease with REMICADE have developed a rare type of
lymphoma that often results in death. These patients also were
receiving drugs known as azathioprine or 6-mercaptopurine. If you
take REMICADE or other TNF blockers, your risk for developing
lymphoma or other cancers may increase. You should also tell your
doctor if you have had or develop lymphoma or other cancers or if
you have a lung disease called chronic obstructive pulmonary
disease (COPD).

Many people with heart failure should not take REMICADE; so
prior to treatment you should discuss any heart condition with your
doctor. Tell your doctor right away if you develop new or worsening
symptoms of heart failure (such as shortness of breath, swelling of
your ankles or feet, or sudden weight gain).

Reactivation of hepatitis B virus has been reported in patients
who are carriers of this virus and are taking TNF blockers, such as
REMICADE. Some of these cases have been fatal. Tell your doctor if
you know or think you may be a carrier of hepatitis B virus or if
you experience signs of hepatitis B infection, such as feeling
unwell, poor appetite, tiredness, fever, skin rash and/or joint
pain.

There have been rare cases of serious liver injury in people
taking REMICADE, some fatal. Tell your doctor if you have liver
problems and contact your doctor immediately if you develop
symptoms such as jaundice (yellow skin and eyes), dark brown urine,
right-sided abdominal pain, fever or severe fatigue.

Blood disorders have been reported, some fatal. Tell your doctor
if you develop possible signs of blood disorders such as persistent
fever, bruising, bleeding or paleness while taking REMICADE.
Nervous system disorders have also been reported. Tell your doctor
if you have or have had a disease that affects the nervous system,
or if you experience any numbness, weakness, tingling, visual
disturbances or seizures while taking REMICADE.

Allergic reactions, some severe, have been reported during or
after infusions with REMICADE. Signs of an allergic reaction
include hives, difficulty breathing, chest pain, high or low blood
pressure, swelling of face and hands, and fever or chills. Tell
your doctor if you have experienced a severe allergic reaction. The
most common side effects of REMICADE are: respiratory infections,
such as sinus infections and sore throat, headache, rash, coughing
and stomach pain.

Please read the Medication Guide for REMICADE and discuss it
with your doctor.

About Centocor

Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform
patients' lives. Centocor has already brought innovation to the
treatment of Crohn's disease, rheumatoid arthritis, ankylosing
spondylitis, psoriatic arthritis, ulcerative colitis, pediatric
Crohn's disease and psoriasis.

The world leader in monoclonal antibody production and
technology, Centocor has brought critical biologic therapies to
patients suffering from debilitating immune disorders.